Notal Vision Chooses TrialStatís Clinicalanalytics 4.0 For Age-Related Macular Degeneration (AMD) Device TrialOTTAWA, ON – December 13, 2007: TrialStat Corporation, the industry’s first clinical data solutions on demand company, today expanded its international customer base with news that Notal Vision™, an Israeli-based medical device company specializing in the early detection of AMD, has selected ClinicalAnalytics 4.0™ (CA) for a Phase II device trial that will occur in Israel and the United States. Notal Vision’s flagship product is The Foresee Preferential Hyperacuity Perimeter (Foresee PHP™), which is a non-invasive diagnostic tool for the detection and monitoring of wet AMD. Wet AMD is the most severe form of AMD. AMD affects approximately 50 million people worldwide.
The medical device company selected TrialStat for its on demand flexibility, the ability to attach images to eCRFs and import data from Notal Vision’s medical devices. A key part of the trial requires independent ophthalmologists to review Foresee PHP’s ability to evaluate the progression of wet AMD in study participants. CA 4.0 allows the study’s researchers to easily attach images of participant eyes to an eCRF to enable ophthalmologists to view them and enter data for analysis in one step, further speeding the collection and management of study data. In addition, patient data from Foresee PHP can be imported to CA 4.0 in XML format for review, allowing for optimal flexibility in capturing trial data.
“TrialStat was unique among EDC vendors in their capacity to provide an integrated image attachment solution that allowed us to quickly deploy our study,” said Miri Sani, Vice President of Clinical and Regulatory Affairs, Notal Vision. “Our ability to use a flexible on demand EDC solution that easily integrated with our management of trial data underscores CA’s robust scalability and innovative image-based tools.”
“Easily attaching images to eCRFs provides our customers with the ability to more effectively and efficiently capture and analyze data,” said Jonathan Barker, President and CEO, TrialStat. “With Notal Vision, we provided an innovative approach to using images so that researchers can intuitively enter data to accelerate the management and completion of their study.”
TrialStat Corporation provides innovative clinical data solutions on demand that optimize the collection and management of research to enable customers to accelerate the commercialization of new life science products. CA 4.0 is a robust and scaleable Web-based EDC on demand platform used by leading biopharma organizations. SRS 4.0™ automates systematic reviews using real-time collaboration and management tools, while ESRNexus™ (www.esrnexus.com) is the most comprehensive and free Webbased search engine for evidence-based reference literature. More information about TrialStat is available at www.trialstat.com.
About Notal Vision
Notal Vision was founded in 2000 by medical professionals from Israel's leading medical centers. The Company has assembled a team of ophthalmologists that have AMD expertise and business experience, R&D specialists, engineers, software engineers, business developers and researchers. Currently, there are 25 full-time employees, of them 4 MDs and 4 PhDs. In addition, Notal has recruited a scientific advisory board that includes leading retinal specialists from around the world. The company is developing the first comprehensive diagnostic solution for the early detection and monitoring of Age-Related Macular Degeneration (AMD), the leading cause of blindness in the western world today. To address the growing need for early detection of wet AMD and for the continuous monitoring of patients with dry AMD, Notal Vision™ has developed the patented Preferential Hyperacuity Perimetery - Foresee PHP platform, designed to detect and monitor the progression of the disease in a non-invasive manner in the clinic or through frequent use at home.
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December 13, 2007
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